Until recently, Philip Morris International (PMI) has been known around the world mostly for its cigarette products, with brands such as global best-seller Marlboro under its umbrella. However, the company has begun moving toward dramatically reinventing itself as a pharmaceutical firm, most recently with the acquisition of respiratory drug developer OtiTopic.
Founded in 2012, OtiTopic is a US-based pharmaceutical company currently working on Asprihale, a late-stage inhalable acetylsalicylic acid (ASA) treatment for acute myocardial infarction. According to the company, if that drug receives approval, it would address a significant unmet need for patients with intermediate to high risk for myocardial infarction (a figure that stands at 83m individuals in the US alone).
Jacek Olczak, CEO of PMI, said the OtiTopic buy is the latest move in the company’s ambitious makeover plans.
“The acquisition of OtiTopic is an exciting step in PMI’s Beyond Nicotine ambitions,” Olczak said. “We have world-class expertise in the research, development, and commercialization of aerosolization and inhalable devices to help speed the delivery of this exciting product to market.”
Last month, Olczak announced PMI’s acquisition of Vectura, another drug developer specializing in inhaled therapies. These purchases are the latest steps in PMI’s Beyond Nicotine “smoke-free transformation” away from its traditional cigarette offerings and toward the growth of a pipeline of inhaled therapeutics and respiratory drug delivery Beyond Nicotine.
PMI’s Beyond Nicotine seeks to harness the company’s repository of knowledge in aerosol chemistry and physics, device technology, clinical research, and preclinical safety and inhalation models to transition to a smoke-free portfolio. To date, the company reports it has invested more than $8b USD in R&D as part of the effort.
PMI is seeking to build its research and development capability, including pre-clinical systems toxicology and clinical capabilities, behavioral research, and post-market studies. The company also plans to bolster its smoke-free tobacco products; in 2020, the US Food and Drug Administration okayed a version of its lead smoke-free tobacco offering as a Modified Risk Tobacco Product.
Asprihale currently is completing clinical trials and awaiting approvals by the US Food and Drug Administration (FDA). Then, PMI reportedly plans to leverage its core expertise and the resources of other components of its Beyond Nicotine portfolio to bring OtiTopic’s Asprihale to market.
Asprihale, a dry-powder ASA inhalation, is expected to achieve approval in 2022. According to PMI, early studies have shown promise in improving the survival of patients who are at risk of heart attack.
“In the United States alone, someone has a heart attack every 40 seconds,” said Jorge Insuasty, chief life sciences officer with PMI. “With its inhalable version of acetylsalicylic acid (ASA), OtiTopic has developed an asset that promises to have a much faster onset of effect compared to oral ASA; with its acquisition of OtiTopic, PMI looks forward to completing the planned ASPRIHALE registration program and bringing this important treatment to market to address a significant unmet medical need in a clinical condition where every second counts.”